New · posted Oct 29
Abbott · Medical Devices
Bioinformatics Quality Engineer I
- La Jolla, CA
- On-site
- Full-time
- Associate & Specialist
The role
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution.
- Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our La Jolla location in the Cancer Diagnostics Division.
The Bioinformatics Quality Engineer 1 is responsible for ensuring the quality of the medical device software for IVD, IUO and LDT products. This entails executing verification activities to ensure quality and compliance for products. The Bioinformatics Quality Engineer 1 will be involved in testing, verification, and validation of the bioinformatics pipelines in all phases of system development. Depending on the area of focus, the position is responsible for ensuring the creation and execution of verification protocols.
Working in a team setting, this role will contribute to the implementation of new software solutions that process and interpret Next Generation Sequencing (NGS) data for cancer diagnostics. This role will work with software and bioinformatics teams to ensure development satisfies requirements, also guiding software changes to ensure adequate testing and compliance for IVD, IUO and LDT products.
With an extensive science and/or engineering background, this role requires a strong focus on quality, testing, integration and attention to detail. It places high value on peer review, software testing and documentation. This position will join a geographically distributed team of highly motivated bioinformatics and software engineers at the forefront of cancer diagnostics and will be required to collaborate closely with scientists, IT and others creating these solutions.
What you need
Minimum Qualifications
- B.S. Degree in Bioinformatics, Computational Biology, Computer Science, Bioengineering or similar field as outlined in the essential duties.
- 0-2+ years of experience spanning software quality/test engineering and/or bioinformatics.
- Knowledge of software development lifecycle (SDLC)
- Familiarity with working in an Agile/Scrum environment.
- Proven capabilities in creating verification documentation: Verification Plan and Reports, Traceability Matrix, and Standard Operating Procedures.
- Understanding of best practices for software development (such as Git, agile, code reviews, CI/CD).
- Experience working within a Quality Management System.
- Excellent communication skills (both written and oral) with the ability to communicate complicated ideas and information effectively at all levels.
Preferred Qualificationsnice to have
- Understanding of bioinformatics pipelines within Next Generation Sequencing and PCR applications.
- Programming Fluency in Python.
- Experience with automated software testing (unit, integration, system, end to end) preferably in the context of medical devices software such as bioinformatics analysis pipelines.
- Familiar with container orchestration concepts and systems, e.g. Docker, Kubernetes, etc.
- Familiar working with cloud platforms (AWS Healthomics, Azure).
- Experience within an FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry, developing CFR 21 Part 11 and IEC 62304 compliant software.
- Experience with medical device requirements such as Quality System Regulation (21 CFR part 820) ISO 14971 Medical Device Risk Management, ISO 13485, etc.
- Familiarity with bioinformatics analysis pipeline frameworks.
- Familiarity with software related Cybersecurity risk management such as FDA Cybersecurity guidance, IEC27000 series, IEC 15408, etc.
- Experience managing requirements in a validated Requirements Management tool such as JAMA.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.
What you'll do
Include, but are not limited to, the following:
- VERIFICATION AND VALIDATION (V&V)
- Develop and execute verification and validation protocols and generate test reports for multiple software solutions used in medical devices and LDT products.
- Translate user and software requirements into executable software verification and validation protocols. This includes the full lifecycle focused on the creation of software requirements, testing, verification, and traceability.
- Work closely with bioinformatics scientists and operations to identify test inputs and provide technical guidance on the development of algorithmic test strategy, testing tools, and testing methodology.
- Test product functionality and/or confirm product capabilities.
- Work closely with Regulatory and Quality to provide the appropriate level of software documentation, compatible with regulatory requirements.
- Communicate documentation requirements to stakeholders across the organization.
- Contribute to test-driven development in the bioinformatics engineering team.
- Work on assignments individually and with project team members to meet department and project objectives.
- Work within project timeframes with successful outcomes on multiple projects and key responsibilities.
- Exercise excellent team working skills with ability to complete collaborative projects on time and within budget.
- Exercise excellent verbal and written communication skills with the ability to communicate complicated ideas and information effectively at all levels.
- Work towards challenging goals in a fast-moving environment where on-time delivery of results is a high priority.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Maintain regular and reliable attendance.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
Pay and benefits
$81,500 – $141,300 a year
Employer providedThe base pay for this position is
$81,500.00 – $141,300.00
In specific locations, the pay range may vary from the range posted.
Free medical coverage through Health Investment Plan (HIP) PPO
Retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit
Career development
Where you'll work
La Jolla, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in La Jolla, CAWorking conditions
Standard
TRAVEL
Yes, 5 % of the Time
MEDICAL SURVEILLANCE
No
JOB FAMILY
Product Development
DIVISION
ONCO Cancer Diagnostics
LOCATION
United States > La Jolla : Torrey Pines Science Park
Equal opportunity, accessibility and legal noticesAbbott's statements, word for word
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Job intelligence
The context around this role
Live data · October 29, 2026
Salary intelligence
How the pay compares
This role's midpoint is 45% above the US median for Validation & CQV roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US25 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $81,500 | — | $141,300 |
| All US (middle half) | $67,500 | $77,000 | $92,000 |
This role: Abbott's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, October 29, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 128 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Abbott's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 45 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Data and digital systems11
- Collaboration and leadership10
- Lab testing and methods7
- Documentation and SOPs5
- Quality systems and risk4
- GMP and compliance3
- Validation and qualification3
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
Company hiring pulse
Abbott on Regulatory Jobs
- 90
- Open roles
- 83
- Distinct roles
- 31
- Locations
By discipline
- Quality60 67%
- Regulatory26 29%
- Compliance & Safety3 3%
By level
- Senior & Principal41 46%
- Associate & Specialist28 31%
- Manager17 19%
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Bioinformatics Quality Engineer I at Abbott
Applications close November 4. $82K–$141K a year, employer provided.